A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
NCT ID: NCT05262400
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
192 participants
INTERVENTIONAL
2022-03-14
2026-08-23
Brief Summary
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* Have been diagnosed with Breast Cancer (BC) of either types:
* Have HR+, HER2- BC
* Refractory HR-positive/HER2-positive BC
* Have other solid tumors other than BC
In part 2, we are seeking participants who:
-Have HR-positive/HER2-negative BC Part 1 will include increasing doses of PF-07220060 with PF-07104091. In part 2, participants will take 1 of 2 study medicine combinations. This will help us decide the highest amount of study medicines that can be safety given to people. All participants in this study will receive PF-07220060 with PF-07104091 by mouth. We will compare participant experiences to help us determine if PF-07220060 with PF-07104091 is safe and effective. Participants will take part in this study for about 2 years. During this time, they will receive the study medicine, an x-ray imaging, and will be observed for safety and effects of the study medicines.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation - Dose Level 1
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Part 1 Dose Escalation - Dose Level 2
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Part 1 Dose Escalation - Dose Level 3
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Part 1 Dose Escalation - Dose Level 4
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Part 1 Dose Escalation - Dose Level 5
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Part 2A
PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior systemic therapy for advanced or metastatic disease, including CDK4/6 inhibitor treatment and Endocrine Therapy)
PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
Part 2B
PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior endocrine therapy and up to 1 prior line of chemotherapy for advanced or metastatic disease and no prior treatment with any CDK4/6 inhibitor for advanced disease)
PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
Part 2C
PF-07220060 + PF-07104091 + Letrozole (ER+/HER2- Breast Cancer with no prior treatment with any CDK4/6 inhibitor for advanced disease)
PF-07104091 + PF-07220060 + letrozole dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with letrozole
Part 1 Dose Escalation - Dose Level 6
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Part 1 Dose Escalation - Dose Level 7
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Part 1 Dose Escalation - Dose Level 8
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Interventions
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PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
PF-07104091 + PF-07220060 + letrozole dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with letrozole
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Eligibility Criteria
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Inclusion Criteria
* HR+, HER2- BC
* Refractory HR-positive/HER2-positive BC
* Part 1: Solid Tumors other than BC
* Part 2:
* HR-positive/HER2-negative BC
* Lesion:
* Part 1: evaluable lesion (including skin or bone lesion only)
* Part 2: measurable lesion per RECIST v1.1
* Prior systemic Treatment
* Part 1: HR-positive/HER2-negative BC
* At least 1 line of SOC, including CDK4/6 inhibitor therapy and Endocrine Therapy, for advanced or metastatic disease.
* Prior chemotherapy in the metastatic setting is allowed.
* Part 1: HR-positive/HER2-positive BC
* At least 1 prior treatment of approved HER2 targeting therapy.
* Part 1: Solid Tumors other than BC
* Participants with no standard therapy available or for which no local regulatory approved standard therapy is available that would confer significant clinical benefit in the medical judgement of the investigator.
* Part 2A: At least 1 prior systemic therapy for advanced or metastatic disease, including CDK4/6 inhibitor treatment and ET.
* Parts 2B: At least 1 prior endocrine therapy for advanced or metastatic disease. Progression during treatment or within 12 months of completion of adjuvant endocrine therapy is acceptable.
* Part 2B: Up to 1 prior line of chemotherapy for advanced/metastatic disease is allowed.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Adequate renal, liver, and bone marrow function
* Resolved acute effects of any prior therapy to baseline severity
Exclusion Criteria
* Part 2B and 1C: Prior treatment with any CDK 4/6 inhibitor, or SERDs (e.g. fulvestrant), or everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway for advanced disease.
* Parts 2B and 2C: Prior treatment with any CDK4/6 inhibitor for advanced disease.
* Parts 2B and 2C: Prior treatment with an investigational endocrine therapy for advanced disease.
* Part 2C: Prior neoadjuvant or adjuvant treatment with a nonsteroidal aromatase inhibitor AI (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.
* Part 2C: Any prior systemic treatment for advanced disease.
* Prior irradiation to \>25% of the bone marrow
* Current use of drugs which have a risk for QTc prolongation
* Current use or anticipated need for food or drugs that are known strong CYP3A4/5, strong UGT2B7 or UGT1A9 inhibitors or inducers
* Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
* Participants with any other active malignancy within 3 years prior to enrollment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, Bowen's disease
* Major surgery within 4 weeks prior to study entry
* Radiation therapy within 4 weeks prior to study entry.
* Clinically important hypertension
* Known or suspected hypersensitivity to PF-07220060, PF-07104091, letrozole, fulvestrant, or goserelin (or equivalent to induce chemical menopause if applicable)
* Known abnormalities in coagulation. Anticoagulation with subcutaneous heparin or prophylactic doses of anticoagulant are allowed
* Known active uncontrolled or symptomatic central nervous system (CNS) metastases
* Active inflammatory GI disease
* Current use or anticipated need for Proton Pump Inhibitors (PPI) within 14 days prior to first dose of the study intervention
* Previous high-dose chemotherapy requiring stem cell rescue
* Participants with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Administrative Address: UCLA Hematology/Oncology
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
UCLA Hematology / Oncology-Parkside
Santa Monica, California, United States
UCLA Hematology/Oncology-Santa Monica
Santa Monica, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Clinica Viedma S. A
Viedma, Río Negro Province, Argentina
Centro Oncologico Korben
Buenos Aires, , Argentina
Clínica Universitaria Reina Fabiola
Córdoba, , Argentina
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, , Argentina
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Clínica - Área Administrativa
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, , Brazil
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, Sofia (stolitsa), Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, , Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, , Bulgaria
Complex Oncology Center - Vratsa
Vratsa, , Bulgaria
The First Hospital of Jilin University
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Fakultni nemocnice Olomouc
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice Bulovka
Prague, Praha 8, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Instituto Nacional de Cancerologia
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Mérida Investigación Clínica
Mérida, Yucatán, Mexico
FARMOVS
Bloemfontein, Free State, South Africa
15 Eton Road
Johannesburg, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
WCR Office
Johannesburg, Gauteng, South Africa
Wits Clinical Research
Johannesburg, Gauteng, South Africa
Wilgers Oncology Centre
Pretoria, Gauteng, South Africa
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-002173-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509504-15-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4391002
Identifier Type: -
Identifier Source: org_study_id
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